SmartHealth Dx
SmartHealth Diagnostics is a specialty diagnostics company developing blood-based molecular tests (SmartVascular Dx, SmartDiabetes Dx) and slide-free digital pathology imaging (MUSE) for cardiovascular, metabolic, and oncological disease detection, serving physicians and hospitals through direct sales and international distribution partnerships.
- Company typePrivate
- Founded2018
- HeadquartersIrvine, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What SmartHealth Dx does
SmartHealth Diagnostics, Inc. (SmartHealth Dx) is a specialty diagnostics company developing precision tests and imaging instruments for vascular, metabolic, and oncological diseases. Founded in 2016 (incorporated 2018) and headquartered in Irvine, California, the company operates as a portfolio company of SmartHealth Holdings, Inc., with wholly-owned subsidiaries Morningstar Laboratories (a CLIA-certified, CAP-accredited clinical laboratory) and MUSE Microscopy Inc. The product portfolio combines molecular diagnostics — SmartVascular Dx (formerly PULS Cardiac Test), a blood-based protein biomarker test predicting five-year heart attack risk, and SmartDiabetes Dx (formerly DIABETESpredict), a polygenic test for Type 2 diabetes predisposition developed with Massachusetts General Hospital and the Broad Institute — with imaging diagnostics via the MUSE (Microscopy with UV Surface Excitation) slide-free digital pathology platform acquired from Lawrence Livermore National Laboratory and UC Davis in 2021. Underlying the portfolio is a proprietary cloud-based Laboratory Information System (PHDC LIS) with HIPAA compliance and API integration, and a multi-omic biorepository of 120,000+ patients.
The company makes money through a hybrid model: (1) specialty diagnostic test sales via its CLIA-certified laboratory using a national sales team of account executives and distribution partnerships; (2) MUSE microscopy instrument sales to hospitals and research facilities with recurring revenue from consumable cartridges; (3) licensing of AI-derived algorithms; and (4) international distribution agreements (Canada via LifeLabs, Indonesia via Prodia, FDA-pending China, North America DIABETESpredict via Patia Europe SL). Pricing is quote-based for both tests and instruments and not publicly disclosed. Customer segments are predominantly healthcare providers — physicians, cardiologists, endocrinologists, and hospital pathology departments — with distribution partners such as Madison Core Laboratories reaching 30+ healthcare facilities serving high at-risk patient populations.
Forward strategic momentum is evidenced by pipeline products (SmartLung Dx, SmartKidney Dx), a 2022 senior leadership buildout (CCO Larry Dentice, President of Laboratory Services Susie Lu, President/CFO Mitch Levine), co-development relationships with Mayo Clinic and the University of Pennsylvania School of Translational Medicine, and a December 2022 corporate rebrand consolidating the product family under the SmartHealth identity. Cumulative scale signals include 120,000+ PULS Cardiac Test orders by June 2021 and 200,000+ patients benefited by SmartVascular Dx.
SmartHealth Dx firmographics
Firmographics- Name
- SmartHealth Dx
- Legal name
- SmartHealth Diagnostics, Inc.
- Website
- https://smarthealthdx.com
- Company type
- Private
- Founded year
- 2018
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- SmartHealth Diagnostics is a specialty diagnostics company developing blood-based molecular tests (SmartVascular Dx, SmartDiabetes Dx) and slide-free digital pathology imaging (MUSE) for cardiovascular, metabolic, and oncological disease detection, serving physicians and hospitals through direct sales and international distribution partnerships.
- Ownership category
- akta.pro rank
SmartHealth Dx industry classification
Industry- Product category
- Precision Diagnostics
- NAICS
- Medical and Diagnostic Laboratories (62151), Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays (HLAAALAN)
- akta.pro secondary industries
- Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Reference & Esoteric Testing Laboratories (HLAFAMAJ), Clinical Chemistry & Immunoassay Laboratories (HLAFAMAB), Hemodynamic Monitoring & Cardiac Diagnostics (Cath Lab, FFR/IVUS/OCT) (HLAHAFAI)
Keywords
Where SmartHealth Dx is headquartered
LocationHeadquarters
- HQ city
- Irvine
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
SmartHealth Dx business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Supply Chain
Revenue model
- Diagnostic Test Sales: Revenue from sale of specialty diagnostic tests including PULS Cardiac Test and DIABETESpredict through CLIA-certified laboratory using national sales team and distribution partners.
- MUSE Microscopy Instruments and Consumables: High-margin medical instruments sold to healthcare and research facilities, with ongoing revenue from sample cartridges that facilitate image production.
- Technology Licensing: Licensing of advanced AI-derived algorithms for disease prediction to healthcare and research facilities nationwide.
- International Distribution Partnerships: Distribution agreements with international partners for market entry globally, including Prodia Clinical Laboratory (Indonesia), FDA-pending China distribution, and LifeLabs (Canada).
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Diagnostic test pricing - quote-based |
Go-to-market motion3 records
Distribution channels8 records
Marketing channels5 records
SmartHealth Dx product offering
Product offeringCore offering
SmartHealth Diagnostics develops and commercializes specialty precision diagnostic tests for vascular, metabolic, and oncological diseases through its CLIA-certified Morningstar Laboratories subsidiary. Its commercial portfolio includes the SmartVascular Dx cardiac risk blood test, SmartDiabetes Dx polygenic test, and the MUSE slide-free digital pathology imaging platform, supported by a proprietary cloud-based Laboratory Information System (LIS).
Product overview
SmartHealth Diagnostics is a specialty diagnostics development platform offering a portfolio of precision diagnostic products. The platform combines molecular diagnostics (SmartVascular Dx, SmartDiabetes Dx) with imaging diagnostics (SmartPath Dx/MUSE microscopy) supported by proprietary cloud-based laboratory information systems. The company serves healthcare providers with tests addressing cardiovascular disease, diabetes, oncology, and other high-risk diseases, using AI-powered analytics and multi-omic data integration (proteomics, genetics, metabolics, biochemistry, phenotype, and imaging) through its CLIA-certified Morningstar Laboratories.
Differentiator
Problem solved
Functional benefit
Brands
- MUSE Microscopy: Microscopy with UV Surface Excitation technology for slide-free digital pathology
- SmartVascular Dx
- SmartDiabetes Dx
- SmartScience Dx
- SmartLung Dx
- SmartKidney Dx
- SmartPath Dx
Products and services
- SmartVascular Dx Diagnostic blood test that identifies vascular inflammation associated with dyslipidemia, hypertension, and diabetes, generating a risk score predicting acute coronary syndrome / heart attack probability over five years. Sold to healthcare providers for use with asymptomatic at-risk patients.
- SmartDiabetes Dx Polygenic laboratory test that evaluates genetic predisposition to Type 2 diabetes and provides personalized prevention recommendations based on patient genetic profile. Ordered by healthcare providers for at-risk patients before symptoms or abnormal labs.
- SmartPath Dx Desktop digital imaging system that produces non-destructive, slide-free evaluation of fresh or preserved tissue samples in minutes for real-time surgical pathology diagnosis, biopsy evaluation, and cancer margin assessment. Used by hospitals, surgical suites, and pathology departments.
- MUSE Microscopy Platform Slide-free digital pathology platform using Microscopy with UV Surface Excitation. Sold to hospitals, research facilities, surgical suites, point-of-care facilities, and veterinary practices, with ongoing consumable (sample cartridge) revenue.
Quantifiable outcome
- 200,000+ patients benefited from SmartVascular Dx diagnostic tool
- +5 more outcomes
Companies that use SmartHealth Dx
Customer profileNamed customers4 records
Segments4 records
Ideal customer profiles3 records
SmartHealth Dx technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability6 records
Feature6 records
SmartHealth Dx partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core, regional and strategic.
- Lawrence Livermore National Laboratory / UC DaviscoreAcquisition of MUSE Microscopy intellectual property portfolio developed jointly at Lawrence Livermore National Laboratory and University of California, Davis. MUSE (Microscopy with Ultraviolet Surface Excitation) is the leading histology-free digital microscope representing the most significant advances in the industry in over 100 years.
- Madison Core LaboratoriescorePartnership with Alabama-based Madison Core Laboratories for distribution of the PULS Cardiac Test to patients throughout the organization's expansive network of high at-risk patients. MCL is a state-of-the-art, full-service independent clinical laboratory servicing physicians' offices, long-term care facilities, assisted living facilities, homebound patients, addiction clinics, and industrial/corporate testing needs across 30+ facilities.
- Patia Europe SLcoreExclusive distribution agreement with Patia Europe SL for North American distribution of DIABETESpredict. Patia developed the test in collaboration with scientists and endocrinologists at Massachusetts General Hospital and The Broad Institute of MIT & Harvard.
- Prodia Clinical LaboratoryregionalDistribution agreement with Prodia Clinical Laboratory to provide the PULS Cardiac Test to the people of Indonesia.
- LifeLabsregionalCanadian distribution partner for PULS Cardiac Test distribution throughout Canada.
- Mayo ClinicstrategicCurrent development partnership with Mayo Clinic following novel discoveries in oncology, autoimmune disease, drug response companion diagnostics, and kidney and liver disease.
- University of Pennsylvania School of Translational MedicinestrategicCommercial partnership established with University of Pennsylvania's School of Translational Medicine; developed one of the world's first multi-omic biomarker discovery laboratories.
- Massachusetts General Hospital / Broad Institute (SIGMA PROJECT)strategicCollaboration partners for DIABETESpredict development. DIABETESpredict was developed in collaboration with SIGMA PROJECT partners including Massachusetts General Hospital and The Broad Institute of MIT & Harvard.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
SmartHealth Dx competitors and assessment
Company assessmentBroad incumbents
- Quest Diagnostics: Quest Diagnostics is a major reference laboratory that has expanded into advanced cardiac risk and inflammatory markers — comparable to SmartHealth Dx as both operate clinical laboratories performing specialized esoteric testing for physicians nationwide.
- Exact Sciences (Genomic Health): Exact Sciences operates a large specialty diagnostics platform spanning oncology (Cologuard) and previously Genomic Health's Oncotype DX — overlapping with SmartHealth Dx's precision diagnostics development model and LDT commercialization in proprietary biomarker tests.
- Myriad Genetics: Myriad Genetics is an established molecular diagnostics company with proprietary tests across oncology, women's health, and mental health — a broad incumbent comparable to SmartHealth Dx's polygenic (SmartDiabetes Dx) and molecular diagnostics approach.
- NeoGenomics: NeoGenomics is a specialty cancer diagnostics company providing oncology testing services — comparable to SmartHealth Dx in operating a high-complexity CLIA-certified laboratory and offering esoteric reference testing for hospitals and physicians.
- Laboratory Corporation of America (LabCorp): LabCorp is one of the largest clinical laboratory networks globally and offers extensive esoteric and specialty testing menus — comparable to SmartHealth Dx's Morningstar Laboratories in providing CLIA-certified reference laboratory services and proprietary test development.
Direct peers
- Natera: Natera is a molecular diagnostics company specializing in proprietary genetic and cell-free DNA tests across reproductive health, oncology, and organ transplantation — directly comparable to SmartHealth Dx's polygenic testing (SmartDiabetes Dx) and proprietary LDT development model.
- Veracyte: Veracyte develops molecular diagnostics for cancer and other diseases using proprietary genomic classifiers — comparable to SmartHealth Dx in operating a CLIA-certified specialty lab, leveraging proprietary biomarkers, and pursuing multi-modality diagnostic platforms.
- Cardio Diagnostics Holdings: Cardio Diagnostics develops AI-driven cardiovascular disease risk tests using genetic and epigenetic biomarkers — directly comparable to SmartHealth Dx's SmartVascular Dx in targeting asymptomatic cardiac risk detection through proprietary blood-based diagnostics.
Emerging players
- Quanterix: Quanterix develops ultra-sensitive biomarker detection platforms used in neurology, oncology, and inflammatory disease research and diagnostics — comparable to SmartHealth Dx in offering proprietary protein biomarker measurement for disease risk prediction (SmartVascular Dx).
- Guardant Health: Guardant Health is a precision oncology company specializing in liquid biopsy and genomic profiling — comparable to SmartHealth Dx in developing proprietary blood-based molecular diagnostic tests, leveraging biorepositories of patient samples, and pursuing AI-driven predictive analytics.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
SmartHealth Dx social profiles
Digital presenceSmartHealth Dx compliance and trust
Trust signalCompliance8 records
SmartHealth Dx financial estimates
Financial estimateRevenue estimate
Valuation estimate
SmartHealth Dx leadership team
Management profileNumber of profiles
Profiles9 records
SmartHealth Dx subsidiaries and ownership
Company hierarchySubsidiaries2 records
SmartHealth Dx funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SmartHealth Dx M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SmartHealth Dx
What does SmartHealth Dx do?
SmartHealth Diagnostics develops and commercializes specialty precision diagnostic tests for vascular, metabolic, and oncological diseases through its CLIA-certified Morningstar Laboratories subsidiary. Its commercial portfolio includes the SmartVascular Dx cardiac risk blood test, SmartDiabetes Dx polygenic test, and the MUSE slide-free digital pathology imaging platform, supported by a proprietary cloud-based Laboratory Information System (LIS).
Is SmartHealth Dx a public or private company?
SmartHealth Dx is a private company. It is classified as corporate owned and is currently operating.
When was SmartHealth Dx founded?
SmartHealth Dx was founded in 2018. It employs 11 to 50 people.
Where is SmartHealth Dx based?
SmartHealth Dx is headquartered in Irvine, United States, in the North America region.
How does SmartHealth Dx make money?
Four revenue lines are on record. Diagnostic Test Sales are the primary driver. The others are MUSE Microscopy Instruments and Consumables, technology Licensing and international Distribution Partnerships.
Who are SmartHealth Dx's main competitors?
Broad incumbents on record are Quest Diagnostics, Exact Sciences (Genomic Health), Myriad Genetics, NeoGenomics and Laboratory Corporation of America (LabCorp). Direct peers are Natera, Veracyte and Cardio Diagnostics Holdings. Emerging players are Quanterix and Guardant Health.
Does SmartHealth Dx have an API?
No public API is recorded for SmartHealth Dx.
What industry is SmartHealth Dx in?
SmartHealth Dx's product category is Precision Diagnostics. Its primary akta.pro industry code is HLAAALAN, Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays, with a secondary code of HLAAAMAC, Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays). Its NAICS code is 62151 and its SIC code is 2835.